Genau & More is a highly specialized consulting company solely working in Life Sciences. We offer specialist knowledge and resources at senior level within compliance, regulatory, quality assurance & control, manufacturing processes and GMP IT & Automation.At Genau & More we are striving to build and develop long-term relationships with our clients build on trust. Jointly with our clients, we lead the field of compliance & quality and together we shape a future based on collaboration-driven excellence. Compliance & quality is a shared dedication.

CONTRACT & LOCAL MANUFACTURINGNovo Nordisk Production responsible for activities at contract manufacturers. CMO and stakeholder management. Accountable for timely delivery of products to meet global demand with strong focus on compliance, quality and production performance Improvement of CMO QMS. Performing assessments of processes and standards and implementing actions in order of complying to regulatory requirements Main Tasks/achievements:Trainer of CMO in GMP, Root Cause Analysis, CAPA, and QA oversight Approval of CMO QMS documents (Validations, Deviations, Changes, PQR/APR, Batch Records) Responsible for Business Review Meetings Customer Complaint Investigator Product in area of responsibility: Insulatard®, Actarpid®, Norditropin® Nordilet® & NovoNorm® Geographical areas of responsibilities: Iran, Belarus, Sweden and Germany Observing role during GMP Audits and Responsible Sourcing Audits Project Manager on Internal Novo Nordisk Compliance projects Investigation Leader on Critical Cases Implementation of Control Cards, administration

Equipment responsible in Tablet production & UtilitiesProject Management, IT AutomationMain roles/tasks:Project Manager for IT/Automation upgrade, BMS Desigo Insight Project Manager for IT/Automation recovery/upgrade on FMS system Project Manager for new Tablet Machine Korsch XL400 Project Manager of Standardization of Granulation, Compression and Coating processes Project manager for implementation of Reliability Centered Maintenance Project Manager of Packaging line optimizations, improving OEE In charge of a project teams of approx. 15 employees, internal and consultants Expert in Systematic problem solving, Cross functional implementation. Trainer of employees in 3 departments. Defining standards and processes for CAPA. Administrator and Equipment Responsible for Automation/IT systems: FMS, BMS, Weighing System, Tablet Machines, Coating, CIP, Water Treatment, Site Domain Controller, Backup Server. Design, implementation and validation of automation systems IT/Automation validation planning and reporting Handling of 21 CFR Part 11 and data integrity Extensive Inspection and Audit experience Responsible for temperature mappings on site Department Lean Responsible. Process Expert in Maintenance for Novo Nordisk globally Deviation and Change Request handling. Ensuring compliance with NN and project standards across within own deliveries and vendor solution

Automation Engineer, Design and Validation of Automation Systems in the Pharmaceutical industry (PLC, SCADA, Batch, PCS)Projects:Lead engineer in Secondary Process Automation. Design, development and validation for a large pharmaceutical company, Toronto, Canada and Philadelphia, US Validation of a vial packaging line, IT/Automation, large pharmaceutical company Clayton, US. Management consulting Value Stream Mapping & Knowledge transfer, large pharmaceutical company, Clayton, US. Secondary Process Automation - Design, development and validation. PLC programming of ControlLogix and IFix VB programming. Large pharmaceutical company, Raleigh, US. Laboratory Automation Development, ASAP System, large biotechnological company, Denmark Detailed design and development of IBatch for Solution Preparation Unit, large pharmaceutical company, Sweden Validation of MES iBatch and iFIX system for formulation & CIP processes, large pharmaceutical company, Denmark Validation of MES system (LMES+) for Purification Facility for Insulin Analogues, large pharmaceutical company, Denmark